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October 14, 2016

Culture of Safety: Nursing, Clinical Research and Healthcare
By Linda Valentino, MSN, RN

On May 7, 2016, Rockefeller University Hospital participated in National Nurses Week, sponsored by the American Nurses Association (ANA), on the occasion of the birthday of Florence Nightingale, the founder of modern nursing.  Our focus was on “a culture of safety” in nursing practice, clinical research nursing, and healthcare delivery.

Why focus on a culture of safety?

A culture of safety is a complex phenomenon, and while healthcare has a long history of patient safety accomplishments, landmark reports such as To Err Is Human, Building a Safer Health System, issued in November 1999 by the Institute of Medicine, identify work still needed to be done. In the past fifteen years, the Agency for Healthcare Research and Quality (AHRQ), Institute for Healthcare Improvement (IHI), The Joint Commission (TJC), and the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) have collectively distributed robust guidance and mandated standards to ensure the protection of the rights, safety, and well-being of patients (National Patient Safety Goals, TJC 2011), (ICH-GCP April, 1996). The Centers for Medicare and Medicaid Services (CMS) and TJC account for safety in payment systems and accreditation conditions. Under the Patient Safety and Quality Improvement Act of 2005, the U.S. Department of Health and Human Services designated ECRI Institute a federal Patient Safety Organization (PSO), to emphasize a Culture of Safety as a critical success factor in healthcare organizations.

Healthcare systems and hospitals have undertaken the ambitious challenge to define and cultivate a safety culture, and have made strides toward wide-scale improvement to proactively identification best practices to improve quality and safety.  Hospitals and healthcare organizations have been informed these reports and agencies and have designed safer and more effective clinical operations.  Changes to clinical operations have included reorganization of organizational structures for example service lines oriented toward specialties such as cardiac, neurological, medical and surgical care to effectively share resources and standardized practice to align with patient safety. Healthcare systems have redesigned policies, procedures and clinical practices to promote the achievement of highly predictable, safe and effective clinical care and operations. Schools of Nursing and Medical Schools have refocused curriculum and competencies that emphasize Quality and Patient Safety concepts, practices and strategies.  These curricula include education and skill building for nurses and physicians to evaluate the safety and effectiveness of clinical practice through the utilization of quality improvement tools.

Some examples of systemic improvements in Quality and Patient Safety have included an estimated decreases of 50% in adverse patient events related to medication administration due to the implementation of electronic physician order entry; a decrease wrong sided surgery and/or misidentification of a surgical patient due to CMS mandated “time out” procedure prior to the initiation of a surgical procedure; improved communication among care providers through the utilization of standardized communication strategies such as SBAR (Situation-Background-Assessment-Recommendation) between nurses and physicians; and the collaborative review of adverse patient events by clinicians utilizing strategies such as Root Cause Analysis (RCA) a process of understanding actual events or near misses for the purposes of improving the care delivery system. Healthcare delivery systems have moved toward Patient and Family centered care to integrate the best current evidence with clinical expertise and patient/family preferences. Overall healthcare delivery systems have evolved and use data to monitor outcomes of care processes and improvement methods to design and test changes to continuously improve quality and safety.

Studies show that a Culture of Safety begins with leadership. When the nurse executive, medical and administrative leaders not only provide an organizations with strategic and financial direction, but also with a centralized and integrated vision of patient safety, the organization is more likely to operationalize safety culture into meaningful, quantifiable metrics, aligned with state, federal, and GCP hospital care standards and mandates.  In the past, healthcare has sought top performing “safety first” organizations, like the aviation industry, for safety models. This work has contributed, for example, to international development of standardized safety procedures, such as the World Health Organization’s recommended surgical team checklist (World Alliance for Patient Safety, 2008) used like a pilot’s pre-flight safety checklist (Frankel & Haraden, 2004). Refinements in our understanding of quality and care-delivery factors have further helped to characterize a Culture of Safety in healthcare. Collectively, research findings illustrate the significance of total system safety that permeates every level of a system to highly reliable organizations (HROs) (Weaver et al, 2013).

The 2016 NIH report, Reducing Risk and Promoting Patient Safety for NIH Intramural Clinical Research distinguishes several themes of importance to quality and risk reduction in clinical research and research-related activities. Although safety culture literature in combined clinical research environments and hospital based-care delivery settings is relatively limited, the larger fund of safety literature in healthcare suggests nursing leadership and engaged nurses are factors meaningful to the cultivation and development of a Culture of Safety (NQF, 2006). From the premise that patient safety is essential to quality care-delivery, research indicates HROs demonstrate a culture of learning, evidence-based practices, and a culture of safety (Carrol & Rudolph, 2006). 

The multi-dimensional domain of clinical research nursing specialty involves the care of research participants and the implementation of clinical-protocols. This role is outlined in the ANA’s Scope and Standards of Practice and the International Association of Clinical Research Nurses’ (IACRN) Scope and Standards of Clinical Research Nursing.  Rockefeller University nurses are well positioned now and into the future to drive the cultivation of a sustainable Culture of Safety along with the dimensions of care coordination and continuity, patient protection, management of clinical and research support activities, research team work, and direct nursing care and support.

Dr. Coller recounts the anecdote of the person calling a hospital and asking the operator, “Who is in charge of safety?”  The operator’s answer was the perfect answer, “We all are!”


Carroll, J.S. & Rudolph, J.W. (2006).  Design of high reliability organizations in health care.  Quality and Safety in Healthcare, 15(Supp I): i4-i9.

National Quality Forum (NQF) Improving Patient Safety by Creating a Culture of Safety, 2006

Sammer, C. E., Lykens, K., Singh, K. P., Mains, D. A., & Lackan, N. A. (June 01, 2010). What is Patient Safety Culture? A Review of the Literature.  Journal of Nursing Scholarship, 42, 2, 156-165.